Neoadjuvant Dupilumab and Cemiplimab in Patients With Early-stage Resectable NSCLC - Trial NCT06088771

Timeline & Enrollment

Primary Outcome

Frequency of dose limiting toxicities (DLTs),Percentage of dose limiting toxicities (DLT),Major pathological response (MPR)

Summary

This is a phase 1/2 study of combined treatment with dupilumab (anti-IL-4Ra) and cemiplimab
 (anti-PD-1) in patients with early-stage, resectable non-small cell lung cancer (NSCLC). The
 study will include participants with a confirmed diagnosis of NSCLC who are deemed to be
 surgical candidates, or patients who have a smoking history and radiographic findings highly
 suggestive if a diagnosis of NSCLC who are scheduled to undergo diagnostic biopsy. On Day 1,
 participants will receive neoadjuvant therapy consisting of 600 mg of dupilumab (2 SC
 injections of 300 mg) and 350 mg of IV cemiplimab. Participants will undergo standard of care
 surgery, which will be scheduled within 7 days of Day 15. Participants will be followed up 30
 days following administration of dupilumab and cemiplimab for adverse event (AE) and dose
 limiting toxicity (DLT) monitoring. Participants will be offered adjuvant therapy as per
 standard of care, outside the context of this clinical treatment, and undergo subsequent
 standard of care monitoring for recurrence. The study team will monitor the status of the
 participant through chart review, or by telephone should the patient not continue to follow
 with a physician at Mount Sinai, for up to 5 years.

ICD-10 Classifications